FDA approves 2 implantable heart devices from Biotronik
The U.S. Food and Drug Administration (FDA) has approved Biotronik's Acticor Sky and Rivacor Sky implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The new technologies will be officially launched at Heart Rhythm 2026 in Chicago.
The company said the new Sky family of devices introduces new technologies to address several clinical challenges, including left bundle branch area pacing (LBBAP), and to improve workflows. The built-in technology includes a new anti-tachycardia pacing (ATP) suite for atrial and ventricular ATP. The devices also use the company's single-lead DX Technology that offers atrial sensing without the need for a second atrial lead.
The new HeartInsight feature provides automatic, multi-parameter insight into worsening heart failure through a single actionable alert, while MRI Guard 24/7 streamlines magnetic resonance imaging (MRI) access by eliminating the need for pre- and post-scan EP programming appointments. The company said this can reduce wait times by up to 48%.
“Acticor Sky and Rivacor Sky bring together what care teams have been asking for, therapy options that closely follow cardiac physiology and features that support daily workflows,” David Hayes, Biotronik chief medical officer, said in a statement.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]